Health Canada posted a “Dear Healthcare Professional” letter on May 31, warning the public and medical community about the potential Essure birth control implant risks. The letter comes after a safety review conducted by the regulatory agency, and was specifically directed to healthcare professionals who perform hysteroscopic sterilization using Essure coil implants sold by Bayer, as well as hospitals and clinics that purchase the device, and the Society of Obstetricians and Gynecologists.

Essure is a form of permanent birth control, which involves the placement of bendable coils into the fallopian tubes. This outpatient procedure causes scar tissue to form around the coils and block the tubes, providing sterilization.

Health Canada indicates that it is working with Bayer to add new label warnings, including a new Boxed Warning section. The new labels will warn of Essure complications that include changes to menstrual bleeding, unintended pregnancy, chronic pain, the risk of Essure migration and organ perforation, allergic and immune system reactions. The agency notes that some of the complications may be serious, and in some cases have led to surgical removal of the Essure implant and a hysterectomy.

In addition, Health Canada says it will work with Bayer to also develop a Patient Information Sheet and Checklist, that patients will review and sign before the device is implanted. The agency said that post-marketing information indicates that some women were receiving the Essure implant without being fully informed of the possible complications.

Essure Lawsuits Over Birth Control Implant Complications

The warning comes following months of debate within the medical community about the risks of Essure implants, and whether the complications associated with the device may outweigh the benefits over other forms of birth control or sterilization.

Last year, the FDA held advisory panel meetings to review the safety of Essure. After considering recommendations from the panel of outside experts, the FDA announced in late February 2016 that much stronger Essure warnings will be required to make sure doctors and women are informed of the potential risks.

Although the product has been sold for the past 14 years, Bayer has also been ordered to conduct additional studies to better understand the safety of the Essure implant, raising questions about why the manufacturer failed to take these steps years ago after receiving complaints.

Throughout the United States, hundreds of women are now pursuing Essure injury lawsuits, alleging that Bayer failed to adequately research the device or warn about the potential risks with the birth control implant. A similar Essure class action lawsuit was filed last year in Saskatchewan, Canada, on behalf of women across the province who have experienced complications after receiving the implant.

An estimated 750,000 women worldwide have undergone Essure sterilization procedures since the device was introduced in 2002. Bayer purchased the Essure product from the original developer, Conceptus, for about $1.1 billion in 2013.